Causality assessment, severity and preventability of adverse drug reactions due to first-line antitubercular agents

Upadhyay, Gunjan and Shukla, Apexa B and Dave, Darshan J (2022) Causality assessment, severity and preventability of adverse drug reactions due to first-line antitubercular agents. Pharmaciana, 12 (2). pp. 235-244.

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Abstract

TB (Tuberculosis) is a common infectious disease affecting humans since very long time.
Multidrug therapy with its associated adverse drug reactions is one of the major concerns for the
management of TB. The current study has been conducted for identifying causality assessment, severity
as well as preventability of first-line anti-tubercular agents. All the diagnosed patients of tuberculosis
attending TB and chest department of tertiary care hospital of western India and received Anti-TB drugs
over 6 months enrolled in the study. Demographic details, suspected drugs/groups, causality assessment,
severity assessment, and preventability assessment were analyzed from reported suspected ADR
(adverse drug reaction) forms. Throughout the research period of 6 months, 500 patients received Anti-
TB drugs. Among them, (10%) 50 patients developed 121 adverse drug reactions. According to the
WHO causality scale, 66 (54.54%) ADRs were classified as ‘probable’ and 53 (43.8%) ADR were
‘possible’. More than half of the reactions (31, 62%) were mild on the severity scale while most of the
ADRs were definitely (34, 68%) preventable as per the preventability scale. Gastrointestinal system is
the most common affected system (54, 47.62%) followed by dermatological disorders (26, 23.01%) and
Liver and biliary system (20, 16.52%). Isoniazid (46, 38%) and Rifampicin (40, 33%) were the common
cause of first-line antitubercular agents for ADRs. ADRs to antitubercular agents are a major concern
for patient compliance. Patient education, intensive reporting, and management can be helpful to
improve the outcome of antitubercular therapy.

Item Type: Artikel Umum
Subjects: R Medicine > RS Pharmacy and materia medica
Divisi / Prodi: Faculty of Pharmacy (Fakultas Farmasi) > S1-Pharmacy (S1-Farmasi)
Depositing User: jurnal pharmaciana
Date Deposited: 21 Jul 2022 06:02
Last Modified: 21 Jul 2022 06:02
URI: http://eprints.uad.ac.id/id/eprint/35940

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